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CTRI Number  CTRI/2025/12/098393 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing usefulness of Magnesium Given by Drip or Nebulizer to Control Blood Pressure and Heart Rate changes During Intubation in Surgery undergoing general anaesthesia 
Scientific Title of Study   Effect of Intravenous versus Nebulized Magnesium Sulphate on Hemodynamic response to Laryngoscopy and Intubation in Adult Patients undergoing Elective Surgery : A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arpith A G 
Designation  PG Resident 
Affiliation  Ramaiah Medical College 
Address  Department of Anaesthesiology Ramaiah Medical College M S Ramaiah Nagar MSRIT Post Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  7204089495  
Fax    
Email  arpithg01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yatish B 
Designation  Professor 
Affiliation  Ramaiah Medical College 
Address  Department of Anaesthesiology Ramaiah Medical College M S Ramaiah Nagar MSRIT Post Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886197658  
Fax    
Email  yatishseeni@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Yatish B 
Designation  Professor 
Affiliation  Ramaiah Medical College 
Address  Department of Anaesthesiology Ramaiah Medical College M S Ramaiah Nagar MSRIT Post Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886197658  
Fax    
Email  yatishseeni@yahoo.co.in  
 
Source of Monetary or Material Support  
Ramaiah Medical College M S Ramaiah Nagar MSRIT Post Bangalore 560 054 
 
Primary Sponsor  
Name  Ramaiah Medical College 
Address  M S Ramaiah Nagar MSRIT Post Bangalore 560 054 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arpith A G  Ramaiah Medical College Hospital  Department of Anaesthesiology M S Ramaiah Medical College M S Ramaiah Nagar MSRIT Post Bangalore 560 054
Bangalore
KARNATAKA 
7204089495

arpithg01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M S Ramaiah Medical College and Hospitals Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous Magnesium Sulphate  IV Magnesium Sulphate 30mg/kg given in pre operative room. 
Intervention  Nebulized Magnesium Sulphate  Magnesium Sulphate 30mg/kg given through nebulization mask in pre operative room. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Aged 18–65 years with American Society of Anaesthesiologists classification I-II Scheduled for elective surgery under general anaesthesia with endotracheal tube insertion. 
 
ExclusionCriteria 
Details  Anticipated difficult laryngoscopy and intubation
Patient with cardiovascular dysfunction or arrythmias
Hepatic or renal impairment
Neuromuscular disorder
Raised intracranial pressure or intraocular pressure
Presence of preoperative oral ulcer, sore throat, pharyngitis
Pregnant patients
Patients allergic to magnesium sulphate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean arterial pressure [MAP] and Heart Rate [HR]  Mean arterial pressure [MAP] and Heart Rate [HR] at baseline, at the time of
study drug administration, 5, 10, and 15 minutes after starting administration of the study drug,
before induction, at the time of laryngoscopy, just after intubation, and 1, 5, and 10 minutes after
intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of propofol consumption  During the
induction of anaesthesia 
Incidence of Sore Throat  Post Operative 
Any adverse effects of
magnesium sulphate, such as intraoperative bradycardia [HR 30 percentage fall from baseline, more more than 20 percentage fall in
MAP from baseline], and postoperative nausea, vomiting, or respiratory depression. 
Intra and Post Operative 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arpithg01gmail.com].

  6. For how long will this data be available start date provided 28-11-2027 and end date provided 01-01-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Laryngoscopy and intubation are essential procedures in general anaesthesia for airway management and ventilation but can trigger sympathetic stimulation, leading to increased heart rate, blood pressure, arrhythmias, and elevated intracranial or intraocular pressure. Various pharmacological and non-pharmacological interventions have been explored to control these hemodynamic changes, but no optimal method has been established. Magnesium sulphate possesses anaesthetic, analgesic, and muscle relaxant properties, acting as a calcium antagonist, NMDA receptor blocker, and inhibitor of catecholamine release. It also induces vasodilation and has antiarrhythmic effects. Intravenous magnesium sulphate has shown efficacy in reducing the adverse hemodynamic response during intubation but may cause side effects such as hypotension, bradycardia, and respiratory depression. Nebulized administration provides better mucosal absorption, fewer systemic effects, and improved patient comfort. This study aims to compare nebulized and intravenous magnesium sulphate in attenuating the hemodynamic response to laryngoscopy, hypothesizing that the nebulized route is not inferior.

In this study, which is a randomized open label trial with a sample size of 84 that will be conducted in  Ramaiah Medical College, Bangalore, we aim to compare the  Effect of intravenous versus nebulized magnesium sulphate on hemodynamic response  to laryngoscopy and intubation in adult patients undergoing elective surgery.

The primary outcome of our study is to compare the HR and MAP following laryngoscopy  and intubation. Monitoring of HR and MAP occurs at specific time points: at baseline, at the time of  study drug administration, 5, 10, and 15 minutes after starting administration of the study drug, before induction, at the time of laryngoscopy, just after intubation, and 1, 5, and 10 minutes after  intubation. Secondary outcomes include the comparison of propofol consumption during the induction of anaesthesia, incidence of Post Operative Sore Throat, and any adverse effects of  magnesium sulphate, such as intraoperative bradycardia (HR 30 percentage fall from baseline, more than 20 percentage fall in  MAP from baseline), and postoperative nausea, vomiting, or respiratory depression.

 
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